BEUDAMED
    Product Code: MTS FDA not classified

    Vials, Challenge, Endotoxin

    Unknown

    Endotoxin Challenge Vials are reference standard devices containing known quantities of bacterial endotoxins used for the quality control and validation of Limulus Amebocyte Lysate (LAL) and other endotoxin detection assay systems in laboratory settings. This device has no assigned device class (class "N") in the FDA database. The product code is MTS with no regulation number assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MTS
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    HE
    Submission Type
    3

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Unclassified Reason

    4